www.HIMSSConference.org
#PrecisionHIT
FEBRUARY 11, 2019
ORLANDO, FL
Four Legal Issues for Providers
of Precision Medicine
Agenda:
• Privacy – the balance between conducting research and
protecting genetic information.
• Regulatory – innovation versus regulation?
• Discrimination – GINA and its gaps.
• Fraud & Abuse – is free or reduced-cost testing allowed?
Why should we care about privacy?
Your genome is more personal than a fingerprint
• It’s unique to you
• It says a lot about you & your health
• Privacy concerns about genetics
• What research is being done and where?
• Publicly available sequence banks
• Uses by law enforcement
• What is appropriate informed consent and when should you get
it?
Privacy Issues
What is appropriate use of genetic information?
Current legal framework:
• HIPAA
— Allows use of data for research
— Allows sharing of “de-identified” data
• OHRP
— Only applies to Human Subjects Research
– Systematic investigation designed to develop or contribute to generalizable
knowledge
Privacy Issues
Common Rule
• Proposed Rule modified Human Subjects Research to include
biospecimens
— Did not include use of data
— 80% of respondents addressing this provision opposed it
• Final rule continues to allow the use of de-identified biospecimens for
secondary research
Privacy Issues
The Final Rule requires:
• Re-examine the definition of the terms "identifiable
private information" and "identifiable biospecimen."
• Assess whether there are "analytic technologies
…generate identifiable private information or
identifiable biospecimens."
• Recommendations on consent, privacy, and data
protections that will go through a public comment
process.
Consent requirements must be balanced with research
needs
Privacy Issues
State law restrictions
• What is research?
• What is allowed without express consent?
Informed Consent Requirements
How much information should be given about tests and the
research?
• About third party collaborations?
• Right to have access to results?
When should consent be done?
• Clinical setting prior to research?
• At the time the research protocol is developed?
Issues in Clinical Care
Variants of Uncertain Significance
• Duty to report?
— Give patient false security
— Give patient unwarranted fear
• Reinterpretation?
— Recontact
— To whom to report
— Billing
• Williams. Athena case update
Direct-to-Consumer Testing
Should patients have access to their genome?
Can they understand the results?
Do they understand consent for research / third party
collaborations?
Open platform services:
• Data available to all
• Use by police
FDA Regulating LDTs
Today, lab test quality governed by CLIA regulations
• NY statutes
FDA would like to require labs get clearance before offering
test
• Some genetics testing considered highest risk
FDA Laboratory Developed Tests
Draft Guidance – October 2014
• https://www.fda.gov/downloads/medicaldevices/deviceregulationandguid
ance/guidancedocuments/ucm416685.pdf
White Paper – January 2017
• https://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalPro
cedures/InVitroDiagnostics/LaboratoryDevelopedTests/UCM536965.pdf
Draft Diagnostic Accuracy and Innovation Act – March 2017
• https://bucshon.house.gov/sites/bucshon.house.gov/files/documents/dai
a%20discussion%20draft.pdf
©MFMER | 18
VALID Act
• Verifying Accurate, Leading-edge IVCT Development
(“VALID”) Act
• https://degette.house.gov/sites/degette.house.gov/files/vali
d_act_discussion_draft_12.6.18.pdf
• Incorporates more feedback from FDA on their recent
Technical Assistance document
• http://www.fdalawblog.net/wp-
content/uploads/2018/08/FDA-LDT-Draft-Leg.pdf
FDA Regulating LDTs
Should genetic testing be subject to higher standards for
accuracy?
• FDA has identified many of these as high risk
Should clinical studies be performed to determine whether
the tests add value to health of patient?
• Adds to cost of healthcare
Where does testing end and practice of medicine begin?
Direct-to-Consumer Testing
• Should patients have access to their genome?
• Can they understand the results?
• Will it cause panic because some variants are of uncertain
significance?
• Office of Civil Rights stated NGS test results should be
part of the “designated record set” under HIPAA.
— Burdensome to lab
— Worrisome to patient?
Discrimination
Genetic Information Nondiscrimination Act
• Became law in 2008
• Goal is to protect individuals from discrimination
based on genetic information
— Health Insurance
— Employment discrimination
— Does not cover life insurance, disability insurance, or
long-term care insurance
Discrimination
Patients worried about results for these purposes
• What if a patient requests to have these results
removed from their medical record?
Out-of-Pocket Max Programs
What’s the issue?
• Testing may be expensive to patient
• Lack of CPT Availability
• Lack of coverage by health plans
— Preauthorization may be required
• Providers want to use labs with limited charges to patients
• Labs try to meet that objective by waiving co-pays, or
guaranteeing a cap on the amount paid out of pocket
Out-of-Pocket Max Programs
What’s the Problem?
• Can be breach of the patient’s health plan
— Tortious interference with contract
• Can violate state laws against deceptive and unfair trade practices
• Fraudulent practices
— Inducement
— Unlawful kickbacks
• Unjust enrichment claims
Out-of-Pocket Max Programs
Several lawsuits calling out practices of:
• “Fee forgiveness” program to members, but members never
received a bill
• Copayments and deductibles routinely waived without regard to
patient’s ability to pay
• Cap on out of pocket – no matter what insurance covers
OIG Advisory Opinion 15-4
• Agreements not to bill for out-of-network fees was rejected as
potential kickback
Out-of-Pocket Max Programs
United Health v. Sky Technologies
• Claimed $50 million in damages
Cigna v. HDL
• Claimed $84 million in damages
DOJ settled with HDL for $48.5 million
• False claims
• Unlawful inducements
Out-of-Pocket Max Programs
United Healthcare memo to labs:
• United Healthcare warns labs against waiving patient fees,
copayments, and deductibles
• “UnitedHealthcare’s benefit contracts exclude coverage for any
out-of-network lab services for which the provider waives the
coinsurance, copayments, or deductibles
• In addition, routine waiver of coinsurance, copayments, or
deductibles may be a violation of the federal False Claims Act,
subject to investigation by the Office of the Inspector General and/or
any applicable state insurance department’s fraud division,” wrote
UHC
Out-of-Pocket Max Programs
OIG Special Fraud Alert
• https://oig.hhs.gov/fraud/docs/alertsandbulletins/121994.html
(December 1994)
•“Routine waiver of deductibles and copayments by charge-
based providers, practitioners or suppliers is unlawful
because it results in (1) false claims, (2) violations of the anti-
kickback statute, and (3) excessive utilization of items and
services paid for by Medicare.”
www.HIMSSConference.org
#PrecisionHIT
Sharon C. Zehe, JD
Mayo Clinic
